Status:
COMPLETED
Pilot Study Using a Pulse Oximeter Derived Photo-plethysmographic Waveform to Guide Hemodialysis Ultrafiltration
Lead Sponsor:
Intelomed, Inc.
Collaborating Sponsors:
Centers for Dialysis Care, Inc
Conditions:
Intradialytic Hypotension
Hypervolemia
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The purpose of this study is to use the photo-plethysmographic \[PPG\] waveform signal to guide the dialysis and ultrafiltration \[UF\] of chronic maintenance hemodialysis patients, and to further the...
Eligibility Criteria
Inclusion
- Age \>18 years
- On dialysis \> 6 months with a stable dialysis program
- Consistent achievement of a spKt/V ≥ 1.2
- HGB ≥ 10 gm% ± ESA support
- Consistent failure to achieve a post weight ≤ dry weight + 0.5Kg
- Able to give informed consent directly
- Frequent hypotensive reactions (≥ 1 / treatment in 4 of last 8 treatments)
- Symptoms of hypotension
- Intervention administered because of IDH (saline, "turn downs, early termination, trendelenberg position)
- Drop in BP irrespective of symptoms. SBP \< 90 mmHG intra or post HD if pre SBP was \> 110 mmHG; SBP \< 85 mmHG or 15 mmHG drop from start if starting BP ≤ 110 mmHG.
- Or judged by the nursing staff to be difficult to achieve dry weight.
Exclusion
- Dialysis Catheter Access that may interfere with continuous data collection, per PI determination. (Catheter access is a relative exclusion based on the history of catheter performance.)
- Cognitive Impairment precluding cooperation, and consent
- Restless or unlikely to wear the monitor head-band
- Too unstable in the judgment of their nephrologist to be included in a study of this nature.
Key Trial Info
Start Date :
September 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2015
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT02264522
Start Date
September 1 2014
End Date
August 1 2015
Last Update
August 30 2016
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Centers for Dialysis Care - East
Cleveland, Ohio, United States, 44106